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A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lurasidone 80mg tablet
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Latuda, Lurasidone

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either: Successfully completed OR Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical
  • Summit Research Group
  • Comprehensive NeuroScience
  • Collaborative Neuro Science Network, Inc.
  • Optimum Health Services
  • California Clinical Trials
  • CA Neutopsychopharmacology Clinical Research Institute (CNRI)
  • Pacific Clinical Research
  • Comprehensive NeuroScience, Inc
  • Segal Institute for Clinical Research
  • Segal Institute for Clinical Research
  • University of South Florida, Department of Psychiatry and Behavioral Medicine
  • Comprehensive Neuroscience, Inc.
  • CNS Research Institute
  • Quantum Clinical Services Group
  • Community Clinical Research
  • Future Search Trials
  • Claghorn Lesem Research Clinic, Inc.
  • InSite Clinical Research
  • CBH Health, L.L.C - Dominion Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lurasidone 80 mg tablet

Arm Description

Lurasidone 80mg oral tablet taken once a day

Outcomes

Primary Outcome Measures

Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study

Secondary Outcome Measures

Full Information

First Posted
July 30, 2004
Last Updated
March 31, 2014
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00088621
Brief Title
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
Official Title
An Open-Label, Multicenter, Twelve-Month Study of Safety and Tolerability in the Treatment of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A 1-year outpatient study to test the safety and tolerability of a new medication in the treatment of schizophrenia
Detailed Description
Study will evaluate long-term safety and tolerability of a new compound in the treatment of patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Latuda, Lurasidone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone 80 mg tablet
Arm Type
Experimental
Arm Description
Lurasidone 80mg oral tablet taken once a day
Intervention Type
Drug
Intervention Name(s)
Lurasidone 80mg tablet
Other Intervention Name(s)
Lurasidone
Primary Outcome Measure Information:
Title
Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must have participated in study D1050196 (A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia) and either: Successfully completed OR Patients must have been discontinued after a minimum of 2 weeks of treatment due to lack of efficacy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Summit Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Comprehensive NeuroScience
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Collaborative Neuro Science Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Optimum Health Services
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
California Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
CA Neutopsychopharmacology Clinical Research Institute (CNRI)
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Pacific Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Comprehensive NeuroScience, Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Segal Institute for Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
University of South Florida, Department of Psychiatry and Behavioral Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Quantum Clinical Services Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78729
Country
United States
Facility Name
Future Search Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Claghorn Lesem Research Clinic, Inc.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
CBH Health, L.L.C - Dominion Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22044
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

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